FDA Warns Recalls Causing Shortage of Common Blood Pressure Drug

FDA Warns Recalls Causing Shortage of Common Blood Pressure Drug

The FDA is warning that there is a shortage of the commonly prescribed blood pressure drug valsartan due to ongoing manufacturing issues in which the drug is being contaminated with a possible carcinogen. The agency also said other angiotensin receptor blockers (ARBs), such as losartan and irbesartan, may become in short supply too.

Since the summer, the FDA has issued recalls for all three drugs – though valsartan has been impacted the most – from some generic manufacturers. Most of the recalled valsartan was made in China. The recalled drugs contain potentially dangerous contaminants, N-nitrosodimethylamine (NDMA) or N-Nitrosodiethylamine (NDEA) , which laboratory studies have shown can cause cancer or liver damage.

“Valsartan products are in shortage, and we know that other types of products may fall into shortage soon,” FDA Commissioner Scott Gottlieb said in a statement.

“We remind patients taking these medications or any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor provides an alternative treatment option,” he added.

Going forward, the FDA’s focus “is to balance the risk of patients ingesting low levels of the impurities (below the interim acceptable levels) for a short period of time with the risk that there is a shortage.”


Jonathan Block

Jonathan Block

Jonathan Block is an associate editor at BioCentury, which provides news and information about the biotechnology and pharmaceutical industries. Prior to joining BioCentury in 2019, Jonathan worked for MedShadow as content editor. He has been an editor and writer for multiple pharmaceutical, health and medical publications, including The Pink Sheet, Modern Healthcare, Health Plan Week and Psychiatry Advisor. He holds a BA from Tufts University and is earning an MPH with a focus on health policy from the CUNY Graduate School of Public Health & Health Policy.


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